DepressionNCT05075629
Anxiety, Depression and Substance Use in Undergraduate Health Science Students During the Covid-19 Pandemic.
An observational study of Depression and Anxiety, run by Universidad Westhill, Facultad de Psicología at 1 site in Mexico.
Trial summary
A study will be conducted with a quantitative approach with correlational scope, observational analytical study, prospective cross-sectional. The objective is to compare the levels of anxious symptomatology, depressive symptomatology and substance use in university students who were exposed to SARS-CoV-2 with those… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression, Anxiety, Substance-Related Disorders
- How many people
- 384 participants
- Where
- 1 siteMexico
- Study dates
- 12 Oct 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Mexican university health students
Who may be able to join
- Be an active undergraduate student at any university
- Be currently taking at least one subject at the University.
- Agree to voluntarily participate in the study.
- Sign the informed consent form.
Who cannot join
- Be studying a postgraduate course at the University
- Students of the University who are receiving psychological or psychiatric treatment during the period of the study.
- Not currently taking any course at the University.
- Those participants who do not answer the scales completely.
- Tener un diagnóstico confirmado de Covid-19 en las últimas 2 semanas
Trial locations and contacts
1 site in 1 country.
About this study
A study will be conducted with a quantitative approach with correlational scope, observational analytical study, prospective cross-sectional. The objective is to compare the levels of anxious symptomatology, depressive symptomatology and substance use in university students who were exposed to SARS-CoV-2 with those who were not.
Read the detailed description
Sampling:
A non-experimental sampling by volunteer subjects is performed, since the subjects will come to the study by a call on social networks.
Scenario:
The evaluation will be carried out in the application called Survey Monkey and will be distributed through social networks.
Methodological guidelines for reporting the study:
The guide to improve the quality of methodological reporting of cross-sectional online studies called CHERRIE will be used.
Sample size:
The infinite population formula for qualitative variables will be used, since we will be working with ordinal variables. In addition to the fact that the total number of observation units is unknown or when the population is greater than 100,000.
The sample size for 100,000 persons should be 384 persons per country, so that 95% of the time the data to be measured is within the ±5% interval with respect to the data observed in the evaluation.
Data analysis
Descriptive statistics were used to analyze the central tendency frequencies of the participants' characteristics. Non-parametric analyses will be applied, because the data do not meet the criteria of normality in the analysis of their distribution, the type of variable and the number of participants; therefore, Spearman correlations will be used to contrast ordinal data. On the other hand, odds ratio analysis will be used to determine the likelihood of a health condition or disease occurring in one population group versus the risk of it occurring in another.
Data analysis for instrument validation
Feasibility: This section will record the time participants took to complete the scale, the difficulties patients encountered in answering questions, and the number of missing values (patients who did not respond) for each question. Items will be analyzed by calculating the frequency of each response category within each item, as well as the blank response rate for each item. Floor and ceiling effects were also analyzed, both for each item and for the overall questionnaire.
Reliability: reliability was assessed by calculating Cronbach's alpha to determine internal consistency.
Validity:
(a) Construct: structural validity (or construct validity) was assessed by exploratory factor analysis using the common factor model, principal component extraction method and Oblimin rotation (if rotation was possible). The K1 rule (eigenvalues greater than one) and Cattell's screen test were used to decide the number of factors contained in the solution. A confirmatory factor analysis was also performed to corroborate the original structure, assuming the existence of a single factor where all items loaded. The maximum likelihood estimation method was used using R studio software.
- Discriminant validity: discriminant validity will be calculated by dividing the sample into quartiles based on the total score of GAD-7 and the PHQ-9 and the upper quartile will be compared with the lower quartile, both for the mean scores of individual items and for the overall score. For other clinical criteria, validity will be assessed by calculating the related mean difference between the mean overall GAD-7 score of the diagnostic groups assigned by the clinical investigator, Student's t-test, Mann-Whitney U-test for independent groups or one-way ANOVAs were used, depending on the number of groups compared.
- Criterion validity: the diagnostic performance curves (ROC curves) were analyzed and the sensitivity and specificity rates were calculated, as well as the positive and negative predictive values of the questionnaire, when comparing the resulting diagnostic classification with the reference clinical diagnosis.
- Convergent validity: the degree of agreement between the GAD-7 and PHQ-9 scales and the Hospital Anxiety and Depression Scale (HADS, anxiety and depression domain) was calculated.
- Conditions
- Depression, Anxiety, Substance-Related Disorders
- Medical subject headings
- Depression, Anxiety Disorders, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
It is a cross-culturally validated instrument and its confirmatory factor analysis suggested that the one-factor structure was a reasonably good fit. The internal consistency of the PHQ-9 was good (Cronbach's alpha> = 0.8) overall and for subgroups defined by gender, literacy, and age. The PHQ-9 demonstrated good predictive validity: participants with a PHQ-9 diagnosis of depression had lower quality of life scores on the overall WHOQOL-BREF scale and on each of its domains. Using the results of the PHQ-9 as a gold standard, the optimal cut-off score of 10. Definition of the variable: A depressive episode is characterized by a period of depressed mood or decreased interest in activities occurring most of the day, almost every day for a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating, feelings of worthlessness or excessive or inappropriate guilt.
Measured: 2 weeks
Generalized Anxiety Disorder scale (GAD-7)
The GAD-7 consists of the 7 items with the highest correlation with the total score of the 13-item scale (r = 0.75-0.85). It is an instrument with cross-cultural validation and analysis of receiver operating characteristics with this set of items showed an area under the curve (0.906) and scales with as much as the full 13-item set. These 7 items also had the highest rank correlations in the development sample (n = 1184) and the 2 replication samples (n = 965 and n = 591). The 2 core criteria (A and B) of the DSM-IV definition of GAD are captured by the first 3 items of the scale.26 Of note, 6 of the 7 items had the highest divergent validity (ie, the largest difference between item-total scale score correlation and item-PHQ-8 depression score correlation [Δ r = 0.16-0.21]). Because each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21.
Measured: 2 weeks
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Validation and cultural adaptation was carried out in university students through a non-experimental ex post facto study with 1,176 undergraduate students, mostly women (70.1%) aged 18 to 23 years (89.5%) and unmarried (87.5%). Concurrent validity was obtained by factor analysis and reliability and correlation tests between the alcohol subscale and AUDIT, the Tobacco subscale and Fargerström's Tes, and the marijuana subscale and the DAST-20. The results found adequate reliability coefficients for the ASSIST subscales for tobacco (alpha = 0.83), alcohol (alpha = 0.76) and marijuana (alpha = 0.73). Regarding interscale correlation, significant correlations were only found with the AUDIT (r = 0.71) and the alcohol subscale.
Measured: 3 months
Secondary outcomes (1)
The hospital anxiety and depression scale (HADS)
The scale was adapted and validated by López-Alveranga et al. (2002). The scale is composed of 14 items and is a Likert-type scale ranging from zero to three, with a minimum score of zero and a maximum score of 21. A score equal to or greater than eight indicates the presence of a probable case of depression. Its reliability is good (α =.86).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start12 Oct 2021
- Primary completion14 Oct 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Westhill, Facultad de Psicología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Hernández Posadas, Master's Degree, Principal investigator, Universidad Westhill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075629
- Sponsor's protocol ID
- UW/FP/IC/PSICOLOGIA/2021/002
- Status last verified
- Apr 2023
- First submitted
- 6 Oct 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety, Depression and Substance Use in Undergraduate Health Science Students During the Covid-19 Pandemic.
- ClinicalTrials.gov ID
- NCT05075629
- Acronym / sponsor ID
- UW/FP/IC/PSICOLOGIA/2021/002
- Conditions
- Depression, Anxiety, Substance-Related Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Universidad Westhill, Facultad de PsicologíaUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study will be conducted with a quantitative approach with correlational scope, observational analytical study, prospective cross-sectional. The objective is to compare the levels of anxious symptomatology, depressive symptomatology and substance use in university students who were exposed to SARS-CoV-2 with those who were not.
Detailed description
Sampling:
A non-experimental sampling by volunteer subjects is performed, since the subjects will come to the study by a call on social networks.
Scenario:
The evaluation will be carried out in the application called Survey Monkey and will be distributed through social networks.
Methodological guidelines for reporting the study:
The guide to improve the quality of methodological reporting of cross-sectional online studies called CHERRIE will be used.
Sample size:
The infinite population formula for qualitative variables will be used, since we will be working with ordinal variables. In addition to the fact that the total number of observation units is unknown or when the population is greater than 100,000.
The sample size for 100,000 persons should be 384 persons per country, so that 95% of the time the data to be measured is within the ±5% interval with respect to the data observed in the evaluation.
Data analysis
Descriptive statistics were used to analyze the central tendency frequencies of the participants' characteristics. Non-parametric analyses will be applied, because the data do not meet the criteria of normality in the analysis of their distribution, the type of variable and the number of participants; therefore, Spearman correlations will be used to contrast ordinal data. On the other hand, odds ratio analysis will be used to determine the likelihood of a health condition or disease occurring in one population group versus the risk of it occurring in another.
Data analysis for instrument validation
Feasibility: This section will record the time participants took to complete the scale, the difficulties patients encountered in answering questions, and the number of missing values (patients who did not respond) for each question. Items will be analyzed by calculating the frequency of each response category within each item, as well as the blank response rate for each item. Floor and ceiling effects were also analyzed, both for each item and for the overall questionnaire.
Reliability: reliability was assessed by calculating Cronbach's alpha to determine internal consistency.
Validity:
(a) Construct: structural validity (or construct validity) was assessed by exploratory factor analysis using the common factor model, principal component extraction method and Oblimin rotation (if rotation was possible). The K1 rule (eigenvalues greater than one) and Cattell's screen test were used to decide the number of factors contained in the solution. A confirmatory factor analysis was also performed to corroborate the original structure, assuming the existence of a single factor where all items loaded. The maximum likelihood estimation method was used using R studio software.
- Discriminant validity: discriminant validity will be calculated by dividing the sample into quartiles based on the total score of GAD-7 and the PHQ-9 and the upper quartile will be compared with the lower quartile, both for the mean scores of individual items and for the overall score. For other clinical criteria, validity will be assessed by calculating the related mean difference between the mean overall GAD-7 score of the diagnostic groups assigned by the clinical investigator, Student's t-test, Mann-Whitney U-test for independent groups or one-way ANOVAs were used, depending on the number of groups compared.
- Criterion validity: the diagnostic performance curves (ROC curves) were analyzed and the sensitivity and specificity rates were calculated, as well as the positive and negative predictive values of the questionnaire, when comparing the resulting diagnostic classification with the reference clinical diagnosis.
- Convergent validity: the degree of agreement between the GAD-7 and PHQ-9 scales and the Hospital Anxiety and Depression Scale (HADS, anxiety and depression domain) was calculated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mexican university health students
Key inclusion criteria (4 listed)
- Be an active undergraduate student at any university
- Be currently taking at least one subject at the University.
- Agree to voluntarily participate in the study.
- Sign the informed consent form.
Key exclusion criteria (5 listed)
- Be studying a postgraduate course at the University
- Students of the University who are receiving psychological or psychiatric treatment during the period of the study.
- Not currently taking any course at the University.
- Those participants who do not answer the scales completely.
- Tener un diagnóstico confirmado de Covid-19 en las últimas 2 semanas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 weeks
It is a cross-culturally validated instrument and its confirmatory factor analysis suggested that the one-factor structure was a reasonably good fit. The internal consistency of the PHQ-9 was good (Cronbach's alpha> = 0.8) overall and for subgroups defined by gender, literacy, and age. The PHQ-9 demonstrated good predictive validity: participants with a PHQ-9 diagnosis of depression had lower quality of life scores on the overall WHOQOL-BREF scale and on each of its domains. Using the results of the PHQ-9 as a gold standard, the optimal cut-off score of 10. Definition of the variable: A depressive episode is characterized by a period of depressed mood or decreased interest in activities occurring most of the day, almost every day for a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating, feelings of worthlessness or excessive or inappropriate guilt.
Generalized Anxiety Disorder scale (GAD-7)
Time frame: 2 weeks
The GAD-7 consists of the 7 items with the highest correlation with the total score of the 13-item scale (r = 0.75-0.85). It is an instrument with cross-cultural validation and analysis of receiver operating characteristics with this set of items showed an area under the curve (0.906) and scales with as much as the full 13-item set. These 7 items also had the highest rank correlations in the development sample (n = 1184) and the 2 replication samples (n = 965 and n = 591). The 2 core criteria (A and B) of the DSM-IV definition of GAD are captured by the first 3 items of the scale.26 Of note, 6 of the 7 items had the highest divergent validity (ie, the largest difference between item-total scale score correlation and item-PHQ-8 depression score correlation [Δ r = 0.16-0.21]). Because each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21.
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: 3 months
Validation and cultural adaptation was carried out in university students through a non-experimental ex post facto study with 1,176 undergraduate students, mostly women (70.1%) aged 18 to 23 years (89.5%) and unmarried (87.5%). Concurrent validity was obtained by factor analysis and reliability and correlation tests between the alcohol subscale and AUDIT, the Tobacco subscale and Fargerström's Tes, and the marijuana subscale and the DAST-20. The results found adequate reliability coefficients for the ASSIST subscales for tobacco (alpha = 0.83), alcohol (alpha = 0.76) and marijuana (alpha = 0.73). Regarding interscale correlation, significant correlations were only found with the AUDIT (r = 0.71) and the alcohol subscale.
1 secondary outcome
The hospital anxiety and depression scale (HADS)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Hernández Posadas, Master's Degree principal investigator
Universidad Westhill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Universidad Westhill, Facultad de Psicología at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.